MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Model Number	RBY2C0825-B
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2020-00928, 3005168196-2020-00929.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a non-penumbra microcatheter.It was reported that the patient had high flow vessels.During the procedure, the physician advanced three ruby coils individually to the target vessel and attempted to form each ruby coil.However, the ruby coils would not form and were re-sheathed.After being re-sheathed, two of the ruby coils were unable to advance out of their introducer sheaths.The physician then re-advanced the third ruby coil, and while placing the ruby coil in the target vessel, the ruby coil formed approximately 70% but flowed back across the splenic artery and past the celiac trunk.Subsequently, the physician decided to re-sheath the ruby coil again; however, it unintentionally detached partially in the microcatheter and partially in the splenic artery.Therefore, the physician flushed the remaining coil out of the microcatheter and into the vessel.No attempt was made to remove the detached ruby coil.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10261128
• Report Number: 3005168196-2020-00927
• Device Sequence Number: 11504192
• Product Code: HCG
• UDI-Device Identifier: 00814548018850
• UDI-Public: 00814548018850
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C0825-B
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F91101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005